Product Classification

• Device: prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer
• Regulation Description: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
• Regulation Medical Specialty: Orthopedic
• Review Panel: Orthopedic
• Product Code: MBH
• Premarket Review: Joint Arthroplasty Devices (DHT6A); Joint Arthroplasty Devices (DHT6A)
• Submission Type: 510(k)
• Regulation Number: 888.3565
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: Yes
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 8-195 ASTM F2024-10 (Reapproved 2016)
  Standard Practice for X-Ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings
• 8-380 ASTM F1160-14 (Reapproved 2017)e1
  Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings
• 8-427 ASTM F1185-03 (Reapproved 2014)
  Standard Specification for Composition of Hydroxylapatite for Surgical Implants
• 8-493 ISO 13779-2 Third edition 2018-12
  Implants for surgery - Hydroxyapatite - Part 2: Thermally sprayed coatings of hydroxyapatite
• 8-516 ISO 13779-4 Second edition 2018-12
  Implants for surgery - Hydroxyapatite - Part 4: Determination of coating adhesion strength
• 8-577 ISO 13179-1 Second Edition 2021-09
  Implants for surgery -- Coatings on metallic surgical implants -- Part 1: Plasma-sprayed coatings derived from titanium or titanium-6 aluminum-4 vanadium alloy powders
• 8-579 ISO 13779-3 Second Edition 2018-12
  Implants for surgery -- Hydroxyapatite -- Part 3: Chemical analysis and characterization of crystallinity ratio and phase purity [Including AMENDMENT 1 (2021)]
• 8-585 ASTM F1377-21
  Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Medical Devices (UNS R30075, UNS R31537, and UNS R31538)
• 8-593 ISO 13779-6 First Edition 2015-01-15 Corrected Version 2016-09-15
  Implants for surgery - Hydroxyapatite - Part 6: Powders
• 11-197 ASTM F983-86 (Reapproved 2018)
  Standard Practice for Permanent Marking of Orthopaedic Implant Components
• 11-199 ASTM F565-04 (Reapproved 2018)
  Standard Practice for Care and Handling of Orthopedic Implants and Instruments
• 11-232 ISO 7207-1 Third edition 2007-02-01
  Implants for surgery - Components for partial and total knee joint prostheses - Part 1: Classification, definitions and designation of dimensions
• 11-281 ASTM F1672-14 (Reapproved 2019)
  Standard Specification for Resurfacing Patellar Prosthesis
• 11-308 ASTM F3161-16
  Standard Test Method for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Femoral Components under Closing Conditions
• 11-311 ISO 14243-2 Third edition 2016-09-01
  Implants for surgery - Wear of total knee-joint prostheses - Part 2: Methods of measurement
• 11-335 ASTM F3141-17a
  Standard Guide for Total Knee Replacement Loading Profiles
• 11-342 ASTM F732-17
  Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
• 11-361 ISO 14243-5 First edition 2019-05
  Implants for surgery - Wear of total knee prostheses - Part 5: Durability performance of the patellofemoral joint
• 11-364 ISO 14243-1 Second edition 2009-11-15
  Implants for surgery - Wear of total knee-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test [Including AMENDMENT1 (2020)]
• 11-365 ASTM F1800-19 e1
  Standard Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements
• 11-367 ISO 14243-3 Second edition 2014-11-01
  Implants for surgery - Wear of total knee-joint prostheses - Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test [Including AMENDMENT1 (2020)]
• 11-368 ASTM F3334-19
  Standard Practice for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Tibial Components
• 11-370 ISO 14879-1 Second edition 2020-07
  Implants for surgery - Total knee-joint prostheses - Part 1: Determination of endurance properties of knee tibial trays
• 11-373 ASTM F1223-20
  Standard Test Method for Determination of Total Knee Replacement Constraint
• 11-374 ISO 7207-2 Second edition 2011-07-01
  Implants for surgery - Components for partial and total knee joint prostheses - Part 2: Articulating surfaces made of metal, ceramic and plastics materials [Including AMENDMENT 1 (2016) and AMENDMENT 2 (2020)]
• 11-377 ASTM F2083-21
  Standard Specification for Knee Replacement Prosthesis
• 11-395 ASTM F1814-22
  Standard Guide for Evaluating Modular Hip and Knee Joint Components
• 11-397 ASTM F3210-22e1
  Standard Test Method for Fatigue Testing of Total Knee Femoral Components Under Closing Conditions
• 11-400 ISO 21536 Third edition 2023-07
  Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants
• 11-406 ASTM F3141-23
  Standard Guide for Total Knee Replacement Loading Profiles
• 11-408 ASTM F2777-23
  Standard Test Method for Evaluating Knee Bearing (Tibial Insert) Endurance and Deformation Under High Flexion

Guidance Document

• Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA

Third Party Review

Not Third Party Eligible